This study is being conducted for US patients in the US only. CAUTION: Investigational product. Limited by FDA regulations to investigational use only.

Is urine leakage interrupting
your daily routine?

Prostate surgery can damage the urethral sphincter, a muscle that controls the release of urine.
After surgery, some men experience urine leakage when they laugh, sneeze, cough, or exercise.

This type of leakage is called stress urinary incontinence (SUI). Although symptoms of SUI may disappear overtime,
some men continue to experience these symptoms and may choose to seek care.

Is this you?

A clinical research study is now enrolling patients to evaluate whether an investigational product may be safe and possibly effective in improving SUI symptoms.

If you have had symptoms of SUI for at least 12 months following prostate surgery, you may be eligible to participate in a clinical research study.

Click the link above, or call 1-877-837-0022 to speak to a study representative to learn more and see if you may qualify to participate in the study.

About the Study

The Male SUI Clinical Research Study

This clinical research study is being conducted to investigate the safety and possible effectiveness of an investigational cellular product in men with (SUI) that developed after prostate surgery.

You will undergo a biopsy to have a small piece of muscle removed from your thigh. Cells from your muscle sample will be processed in a laboratory, and then be injected into your urethral sphincter, a muscle that controls the release of urine. The study will evaluate safety of the injection and changes in your SUI symptoms.

You will receive a follow-up phone call 1 week after the biopsy procedure. You willreceive a call at 1-2 days, 1 week, and 24 months after the injection procedure. Additionally, your doctor will evaluate changes in your SUI symptoms during 4 in-office evaluations at 1 month, 3 months, 6 months, and 12 months after the injection procedure. These visits may include pad tests to determine the amount of urine leakage, blood testing, and urine testing. You will also be asked questions about your lifestyle and quality of life.

Click the link above, or call 1-877-837-0022 to speak to a study representative to learn more and see if you may qualify to participate in the study.

Eligibility

Are you eligible to participate?

Men ages 18 and older who have symptoms of SUI for at least 12 months following a prostate surgery may be eligible to participate.

There are additional criteria that you will have to meet to be eligible for the study, and other factors may exclude you.

Only a clinical research team member can determine if you can participate.

Click the link above, or call 1-877-837-0022 to speak to a study representative to learn more and see if you may qualify to participate in the study.

Frequently Asked Questions

If I participate, how many times do I have to go back to the doctor's office and how long is the study?

In total, there are up to 9 planned visits during the Male SUI Clinical Research Study, including pre-procedure screening visits. Your participation in the study is expected to last approximately 12 months from the time of the first initial visit.

May I speak to a study representative on behalf of another person?

No. The study representative will need to speak directly to the potential study participant to determine if he may be eligible to participate and is willing and able to consider participating in the screening process and in this study.

What is being tested?

This clinical research study evaluating whether an investigational product that uses a patient’s own cells may be safe and possibly effective in improving stress urinary incontinence symptoms in men who have had prostate surgery.

What are the responsibilities of study participants?

Participants must agree to have a muscle biopsy conducted, receive one injection of the study product, complete pad tests to measure leakage, and return for scheduled follow-up visits for further evaluation. During these visits, you will be asked questions about your lifestyle and quality of life. Certain lab tests, such as blood and urine testing, will also be conducted. Participants are free to leave the study at any time.

When will I know if I am eligible?

If you meet the initial screening criteria and have given your permission to provide your contact information to the research site in your area, the study site will contact you and will determine your eligibility.

How will my medical information be kept confidential?

Any information you provide to study representatives prior to your enrollment in the study, such as contact information entered at this website or information shared with a study representative during screening, will be collected, recorded and/or stored only with your approval and only for the purposes of assessing your eligibility for the Male SUI Clinical Study. Your information will be kept confidential and will not be disclosed, shared or distributed without your express permission.

Your information will be secured using controlled network barriers (firewalls), data encryption, restricted and logged access and by physical means.

For additional information on your privacy during study screening, please refer to the Male SUI Clinical Study Screening Privacy Policy.

Are clinical research studies safe?

Before participating in a clinical research study, a participant must agree to meet with a physician who is an investigator in the study to learn about the study in detail and then sign an Informed Consent Document. This document provides detailed information about the safety of a study and study procedures. For more information on clinical research studies, visit: www.clinicaltrials.gov/ct/info.

Why might I be excluded from the study?

The study product needs to be evaluated in people whose medical histories are similar. This helps the researchers and regulatory authorities determine whether the investigational product is safe and effective for the use that is being tested. If your medical and health profile indicates that your medical condition does not fit with this study’s eligibility criteria, you will not be able to participate in the study.

Are there any other clinical studies for this condition?

To find out about other clinical research studies, please visit www.clinicaltrials.gov, www.centerwatch.com, or www.searchclinicaltrials.com.

What if I get in the study and decide I do not want to participate anymore? Can I drop out?

If you decide you do not want to be in this study, you may discontinue participation at any time.

Click the link above, or call 1-877-837-0022 to speak to a study representative to learn more and see if you may qualify to participate in the study.

See If You May Qualify

Your answers to the online assessment indicate that you are not eligible to participate in this clinical research study. May we notify you if the current protocol happens to change, if you might qualify for future clinical research studies, or with additional information regarding related care or educational events in your area? If so — Please provide your contact information below if you would like to be contacted in the future.